Cleared Traditional

K151491 - Falck Medical Multifunction Tonometer, FAT1

K151491 is an FDA 510(k) clearance for Falck Medical Multifunction Tonometer, manufactured by Falck Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K151491 · Falck Medical, Inc. · Ophthalmic device
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Jan 2016
Decision
226d
Days
Class 2
Risk

K151491 is an FDA 510(k) clearance for the Falck Medical Multifunction Tonometer, FAT1. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Falck Medical, Inc. (Mystic, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 226 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Falck Medical, Inc. devices

FDA 510(k) Submission Details - K151491

510(k) Number K151491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2015
Decision Date January 15, 2016
Days to Decision 226 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 110d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

Product Code HKY Tonometer, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKY Tonometer, Manual

All 37
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K151491.
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KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
K152644 · Keeler Limited · Dec 2015
Sensor Medical Single Use Tonometer Prism
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D-KAT Z-YPE
K142179 · Keeler, Ltd. · Sep 2014